Participate in Acute Hyposalivation Study

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Stanford & UCSF researchers need healthy, non-smoking volunteers between the ages of 18 and 55!

The Experiment: We hope to learn how medication-induced reductions in salivary images-3
flow impact the structure of human oral microbial communities. Ultimately, we are interested in developing novel, ecologically-based therapeutics & diagnostics for individuals with salivary gland dysfunction due to medications, aging, autoimmune disorders or radiation therapy. We will ask participants to use a Transderm Scop patch for a maximum of 16 days, in order to simulate a drought in the oral cavity. Transderm Scop reduces salivary flow by about 50% in roughly 70% of volunteers. We will track microbial community composition at each site in the oral cavity before, during, and after the simulated drought. For a full description of our research objectives, please visit the Understanding Acute Hyposalivation and the General Projects pages.

Front view of red cartoon alarm clock with light gray face and dark gray hands, two bells on top with sliver handle and small hammer, two dark silver feet serves as stand, confused and quizzical, eyes wide open looking at drifting Question Mark sign, mouth slightly opened with visible pink tongue, black straight eyebrows slightly raised but sloping

What would be my time commitment? This research study is expected to require a maximum of 43 days of participation. In total, the maximum amount of time we ask volunteers to contribute is about 35.5 hours.

What will we ask volunteers to do? We will ask you to take a medication, which may cause dry mouth, for a maximum of 16 days. In addition, we will ask volunteers to participate in the home sample collection protocol as well as the clinical sample collection protocol, as detailed below.

1. Home sample collection protocol: engaging the citizen scientist in each of you!

Screenshot 2016-07-27 10.06.31To understand how microbial communities in the mouth vary from place to place and 
over time, we will ask 77 healthy, non-smoking volunteers to take samples from the front and back surface of each of 12 teeth on a daily basis over the course of 36 consecutive days. We will also ask you to sample saliva and a maximum of 7 oral mucosal surfaces. Home sample collection takes approximately 15-30 minutes each day on average. We ask volunteers to avoid eating, drinking or performing oral hygiene for a two-hour period before sample collection. Volunteers are also asked to collect samples at about the same time each day. Finally, we ask volunteers to make daily entries into an online laboratory notebook.

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We will train volunteers on dental anatomy (i.e., “Calibration”), so they are able to identify the sample sites under investigation in this study. We will also provide volunteers with all the soft, sterile foam swabs needed to perform home sample collection. We will ask volunteers to temporarily store samples in their home freezers until samples can be transported, by the volunteer, to the dental clinic at UCSF.

The hundreds of samples you collect will generate gigabytes of data!

2. Clinical sample collection protocol: collaborating with our clinical team!

We will ask volunteers to attend a 1-1.5 hour appointment at the UCSF School of Dentistry Oral Medicine Clinic once per week over the course of 43 days in order to allow a clinician to collect samples, to measure the salivary flow rate, and to measure dental plaque pH. In addition, we will assess each subject’s understanding of oral dental anatomy at each clinical sample collection appointment. 

What will we do with the samples we collect? We will extract genomic DNA Screen Shot 2014-01-13 at 9.44.57 PMfrom each of the samples we collect. We will perform DNA sequencing to identify the composition and relative abundance of the bacteria present in each of the samples. In addition to sequencing the DNA of bacteria, we will use mass spectrometry to identify small molecules that are produced by the bacteria present in a select subset of samples. We will perform statistical tests to evaluate the spatial and temporal variation of bacterial communities within individuals and among individuals sampled in this experiment.

What are the costs of participation? There will be no costs to volunteers for participating in this research study. We will provide volunteers with a parking sticker to cover the cost of parking in the Millbery Union Parking Garage for the duration of each clinical sample collection appointment.

Benefits-500_26What are the benefits to participants? Participants will receive a no-cost dental examination, a maximum of $325, and the satisfaction of helping advance our understanding of the microbial ecosystem that defines human health!

How can I find out if I’m eligible to participate? We will ask volunteers to complete a telephone interview (Step 1) and a 2-hour dental examination at the UCSF School of Dentistry (Step 2) before enrolling eligible subjects (Step 3).

What are the eligibility criteria? Individuals should be between the ages of 18 and 55 with healthy mouths as defined by a lack of periodontitis, halitosis, unrestored dental cavities or oral mucosal disease. They must be willing and able to restrict exposure to intense heat, exercise, and underwater sports, and must not operate heavy machinery on a regular basis, during participation in this study. In addition, whether male or female, sexually-active individuals must be willing and able to use two methods of birth control during participation in this study.

stopExclusion Criteria: Individuals should not be under the care of a physician for any chronic condition requiring treatment, should not be taking any medication other than birth control on a daily basis, should not have used oral, systemic antibiotics or antifungals within the preceding 6-months, and should not have a history of drug abuse or of eating disorders.

For a full disclosure of eligibility restrictions, as well as a list of the risks and benefits of study participation: please download the Written Informed Consent Form.

Where can I get more information? For additional information, please contact the study team by email at HyposalivationStudy@UCSF.edu or by phone at (415)-696-2377.

Funding
nidcr_logoThis not-for-profit research project is funded by a National Institute of Dental and Craniofacial Research grant (R01-DE23113-001) to Dr. David Relman.

 

 For general information about participant rights, contact 1-(866)-680-2906.